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Health Highlights: March 22, 2019
Posted today in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: 'Game of Thrones' Actress Had Two Brain Aneurysms "Game of Thrones" actress Emilia Clarke disclosed Thursday that she's had two surgeries for brain aneurysms. In 2011, she developed a sudden, severe headache while working out and was rushed to a hospital. Doctors discovered two brain aneurysms, which occur when a... Read more
Tyson Recalls 69,000 Pounds of Chicken Strip Products
Posted today in News for Health Professionals
FRIDAY, March 22, 2019 -- More than 69,000 pounds of frozen, ready-to-eat chicken strip products have been recalled by Tyson Foods because they may contain pieces of metal. The products were produced on Nov. 30, 2018, and shipped across the United States, the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) said. The problem was discovered through two consumer complaints about pieces of metal... Read more
FDA: Higher Risk for Death Found With Venclexta in Multiple Myeloma
Posted today in News for Health Professionals
FRIDAY, March 22, 2019 -- A safety statement was issued yesterday by the U.S. Food and Drug Administration regarding risks found to be associated with the investigational use of Venclexta (venetoclax) for treatment of patients with multiple myeloma. Venclexta is currently not approved to treat multiple myeloma. The FDA conducted a review of the BELLINI clinical trial (NCT02755597, Study M14-031), a phase 3,... Read more
Analysis IDs Messages Behind Antivaccination Comments
Posted today in News for Health Professionals
FRIDAY, March 21, 2019 -- Arguments against vaccination remain consistent within subgroups of individuals, according to a study published online March 18 in Vaccine. Beth L. Hoffman, from the University of Pittsburgh School of Medicine, and colleagues used data from 197 individuals who posted antivaccination comments in response to a message promoting vaccination posted on Facebook. Publicly available content was... Read more
American College of Cardiology, March 16-18
Posted today in News for Health Professionals
The American College of Cardiology's 68th Annual Scientific Session and Expo The annual meeting of the American College of Cardiology was held from March 16 to 18 in New Orleans and attracted more than 20,000 participants from around the world, including clinicians, academicians, allied health professionals, and others interested in cardiology. The conference highlighted recent advances in the treatment, management,... Read more
Stricter Gun Laws Tied to Safer High Schools
Posted today in News for Health Professionals
FRIDAY, March 22, 2019 -- The adoption of stricter state gun laws is associated with improvements in school climate, including fewer students carrying weapons, according to a study published online March 21 in the Journal of Epidemiology & Community Health. Marco Ghiani, Ph.D., from Boston College, and colleagues analyzed self-reported data from 926,639 adolescents from 45 states participating in the 1999 to... Read more
Extra Calcium Safe for the Aging Eye
Posted today in Medical
FRIDAY, March 22, 2019 -- To take calcium or not to take calcium, that is still the question. In a new study that contradicts earlier research, investigators found that adding calcium to your diet will not raise your risk of a common age-related eye disease. That disease, age-related macular degeneration (AMD), is a leading cause of vision loss and blindness among Americans aged 65 and older. In the new research, a... Read more
Affordable Care Act Brought Big Benefits to Women: Study
Posted today in Medical
FRIDAY, March 22, 2019 -- More American women had health insurance and access to care after the Affordable Care Act (ACA) was fully in place in 2014, and poorest women benefited most, according to a new report. For the study, researchers examined U.S. National Health Interview Survey data on insurance affordability, access to care and the use of preventive services -- such as flu vaccination, mammograms, and blood... Read more
Managing MS
Posted today in Medical
FRIDAY, March 22, 2019 -- Proper treatment can help people with multiple sclerosis (MS) contend with their disease, an expert says. "Patients get a predisposed feeling that their life is doomed. That it's going to be a complicated life, which isn't necessarily so," said Dr. Cary Twyman, a neurologist at Penn State Health. "There are many misconceptions and false information about MS on the internet, so I make sure... Read more
AHA News: Is the New 'Fasting' Diet Trend Healthy?
Posted today in Medical
FRIDAY, March 22, 2019 (American Heart Association News) -- Tipping the scales at 233 pounds, Charles Joy realized he needed to make some changes. The 28-year-old Louisville, Kentucky, native already had tried many diet plans to varying degrees of success. In 2013, he lost more than 100 pounds through exercise and diet. But afterward, his weight slowly began to creep back up. In 2017, Joy decided to try... Read more
FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Posted 2 days ago in New Drug Approvals
DUBLIN, March 20, 2019 /PRNewswire/ -- Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved Sunosi (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Once-daily Sunosi is approved with doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and... Read more
FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression
Posted 3 days ago in New Drug Approvals
March 19, 2019 -- The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. "Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or... Read more
FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
Posted 4 days ago in New Drug Approvals
South San Francisco, CA -- March 18, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). This approval is based on results from... Read more
Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
Posted 4 days ago in New Drug Approvals
DUBLIN, March 18, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam), expanding the label to include pediatric patients 3 months and older for the treatment of complicated intra-abdominal infections (cIAI) in combination with metronidazole and... Read more
Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
Posted 9 days ago in New Drug Applications
SOLANA BEACH, Calif., March 14, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has submitted its response to the U.S. Food and Drug Administration’s (FDA) multi-disciplinary review (DR) letter that was received on March 1, 2019 in association with the Gimoti 505(b)(2) New Drug... Read more
Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
Posted 9 days ago in New Drug Applications
NEWTON, Mass., March 14, 2019 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. The NDA, which is currently under Priority Review by the FDA, is seeking accelerated approval for... Read more
Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
Posted 10 days ago in New Drug Applications
TOKYO and STAMFORD, Conn. – March 12, 2019 – Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Imbrium Therapeutics L.P. (Imbrium Therapeutics), a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma, L.P. (President and CEO: Craig Landau, MD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for... Read more
FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension
Posted 10 days ago in New Drug Approvals
DURHAM, N.C.--(BUSINESS WIRE)--Mar. 12, 2019-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved... Read more
Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Posted 11 days ago in New Drug Applications
DUBLIN, March 11, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults. The NDA filing is based on the successful completion of four clinical trials – two pivotal studies, ACHIEVE I and ACHIEVE II, which demonstrated the efficacy,... Read more
TB Medicine Pretomanid Enters Regulatory Review Process in the United States
Posted 2 weeks ago in New Drug Applications
NEW YORK, NY (March 8, 2019)—TB Alliance’s new drug application (NDA) for the novel tuberculosis (TB) drug candidate pretomanid has been accepted for review by the United States Food and Drug Administration (FDA). The application is for the use of pretomanid as part of a new regimen, in combination with bedaquiline and linezolid, for the treatment of extensively drug-resistant (XDR) TB, treatment... Read more
Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer’s Disease
Posted yesterday in Clinical Trials
CAMBRIDGE, Mass., March 21, 2019 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced the decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. The decision to stop the trials is... Read more
Vaxart Announces Initiation of Bivalent Norovirus Vaccine Phase 1b Clinical Trial
Posted 3 days ago in Clinical Trials
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Mar. 19, 2019-- Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced the initiation of a Phase 1b bivalent norovirus vaccine clinical trial. “The initiation of the bivalent norovirus vaccine Phase 1b trial marks a significant step towards our goal of... Read more
Data From GARNET Study Indicates Robust Activity of Dostarlimab in Patients with Advanced or Recurrent Endometrial Cancer
Posted 3 days ago in Clinical Trials
London UK - 19 March 2019 -- TESARO, an oncology-focused business acquired by GlaxoSmithKline plc (LSE/NYSE: GSK), announced today the presentation of data from the Phase 1/2 GARNET study evaluating dostarlimab in women with recurrent or advanced endometrial cancer who progressed on or after a platinum-based regimen. These data were presented at the 2019 Society for Gynecologic Oncology (SGO) Annual Meeting on... Read more
Urovant Sciences Announces Positive Topline Results from Pivotal Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder
Posted 4 days ago in Clinical Trials
IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Mar. 19, 2019-- Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced positive topline results from EMPOWUR, an international double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the efficacy and safety of... Read more
Biohaven Enrolls First Patient In Phase 3 Spinocerebellar Ataxia Clinical Trial Of Troriluzole
Posted 9 days ago in Clinical Trials
NEW HAVEN, Conn., March 14, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today announced that it has enrolled the first patient in a Phase 3 clinical trial assessing the efficacy and safety of troriluzole in Spinocerebellar... Read more
